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Article History

Received: 30 January 2023

Accepted: 1 August 2023

First Online: 13 August 2023

Declarations

:

: This protocol, version I, 1^st July 2022, has been approved by the research ethics committee of the coordinating center (Comitato etico interaziendale di Novara, Prot. N°762/CE, 16/09/2022). The study will start in each participating center only after being approved by the local ERB. Written, informed consent to participate will be obtained from all participants.

: Upon request, the authors will provide a model consent form.

: RV received an honorarium for a lecture from Intersurgical (2021). CG received speaking fees from Mindray, Air Liquide. He also received honoraria for consultancies from Mindray. ACo received an honorarium for lectures from Gilead, MSD, Mundipharma, and Pfizer, and for the advisory board from Gilead and Mundipharma. CC received honoraria for lectures from Fisher & Paykel, ResMed. FL contributed to the development of a new helmet, and he is designated as an inventor (European Patent number 3320941) not related to the present manuscript. He also received speaking fees from Draeger, Intersurgical, and Fisher & Paykel. GC declares speaking honoraria from Getinge and MSD. GM declared a patent in association with the University of Palermo-Italy (No 102019000020532-Italian Ministry of Economic Development). SMM participated on an Advisory Board for Sanofi and received lecture fees from GE Healthcare, Masimo, Aspen, and Getinge. PN receives Royalties from Intersurgical SPA for Hemet Next invention. His research lab received grants/equipment from Intersurgical SPA, Draeger, and Mindray. He also received speaking fees from Mindray, Getinge, Draeger, Gilead, Intersurgical SPA, MSD, and GSK.LS, NDV, AC, AM, RS, ER, SS, SN, and ADM have no competing interests.